How do I randomise if I cannot access Sealed Envelope?

There may be rare occasions when you cannot access Sealed Envelope, either because of an issue with your internet access or down-time at Sealed Envelope. The trial coordinating centre should be prepared for this event and have a back-up procedure in place. This will usually be described in a randomisation SOP. Common strategies are:

• Wait until the service is accessible again
• If local access is the problem, ask a user with an administrative account (such as the trial manager) to perform the randomisation on behalf of the investigator
• If randomisation cannot wait, for example because the treatment must be administered very soon after enrolment in the trial, perform a manual randomisation. This may involve phoning the trial coordinating centre to be issued with the next treatment from a predefined emergency randomisation list the centre has drawn up in advance.
• Alternatively it may involve taking the next available vial/kit/treatment pack from stock in a double blind drug trial.